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2020第二届亚洲生物制药连续生产及工艺创新峰会

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2020第二届亚洲生物制药连续生产及工艺创新峰会

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Event Backgroud 大会背景

      随着生物制药行业的飞速发展,药企将会布局越来越多的项目管线以及开发多样化的药物分子。近些年,药品审评审批制度的改进,使得大批生物药进入临床的步伐大大加快,从而惠及更多的患者。然而,对于生物制药企业而言,机遇与挑战并存,生物类似药的竞争将会愈演愈烈,一方面,如何有效降低成本,造福更多的患者;另一方面,如何提高产品质量,赢得更多的市场份额,已成为生物药企的生存法则。

     与此同时,包括FDA,EMA, PMDA在内的法规监管部门开始更多关注连续制造工艺并鼓励制药企业用更有效的制药工艺来生产更安全、更稳定、更经济的药物。早在2017年,FDA就发布了连续制造(Continuous manufacturing)的意见征求稿;2019年2月26日,FDA颁布了连续制造的指南草案,对于连续制造的法规指导做了进一步说明。

     越来越多的生物制药企业,选择一次性生产设备和将上、下游工艺由批次生产向连续生产转移,来提高产能和节约成本。其中,连续灌流培养技术是连续生产的上游细胞培养工艺,相对于目前主流的补料批次培养,灌流培养工艺从根本上解决营养物耗竭和代谢副产物累积的矛盾,可以显著提高培养过程中的细胞密度,最大化工厂的生产力,降低生产成本。2019亚洲生物制药连续生产峰会将从监管角度,工艺角度,聚集亚太主流生物药企,CDMO,主流工艺供应商探讨连续生产的未来, 期待大家的参与。


Agenda 会议日程

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Keynote 大会嘉宾
首席执行官  复宏汉霖Scott Liu 刘世高博士 (TBD)
Scott Liu 刘世高博士 (TBD)
首席执行官 复宏汉霖
刘世高博士, 复星国际全球合伙人,复宏汉霖联合创始人、总裁兼首席执行官。在他的带领之下,复宏汉霖致力于应用前沿技术进行单克隆抗体生物类似药、生物改良药以及创新单抗的研发及产业化,专注于提供质高价优的生物药,已成为中国单抗领域的领跑者。在2010年组建复宏汉霖之前,刘博士曾先后担任美国UBI公司副总裁、美国百时美施贵宝(Bristol-Myers Squibb)公司及安进(Amgen)公司的质量控制总监,拥有超过25年的生技药品研发、生产制造、药政及质量管理经验。由于其杰出成就,刘博士曾获得施贵宝公司的技术运营成就奖和瞩目焦点奖。刘博士为推动国内蛋白药物质量标准建立与提升做出了具体贡献; 在国内率先引进先进的一次性生产技术用于单抗药物研发以及产业化生产; 并积极参与《生物类似药研发与评价技术指导原则》的意见征询,推动国内生物医药行业健康发展。刘博士于1991年获得美国普渡大学生物系博士学位,而后于斯坦福大学进行博士后研究,并攻读雪城大学iMBA课程。
副总裁,药明生物Peter Shen 沈克强
Peter Shen 沈克强
副总裁,药明生物
25年以上纯化工艺开发和GMP生产经验,曾任美国Laurate Biopharm纯化及GMP生产总监,美国强生公司高级研究员、经理,曾就职于百时美施贵宝和杜邦制药,新墨西哥州立大学硕士。
恒瑞医药副总经理刘洵博士
刘洵博士
恒瑞医药副总经理
刘洵博士,北京大学化学系本科毕业,1993年获得美国罗格斯大学生物化学博士学位,同年获得博士后奖学金,在诺贝尔奖获得者Gobind Khorana教授所在的麻省理工大学从事蛋白生物研究,在此完成三年半的博士后研究。在国外有影响力的期刊发表诸多学术论文。 刘洵博士拥有20多年的生物制药研发,临床和工业生产经验,在制药领域涉及很多新药研发以及工艺优化的研究,包括从临床前的研究开发直至商业生产。 加入恒瑞医药前,他是美国国立卫生研究院疫苗研究中心疫苗生产项目的工艺开发总监。负责大分子药物开发和临床药物生产,期间完成多个生物药物的临床申报。在加入美国国立卫生研究院(NIH)疫苗研究中心之前,刘洵博士担任位于美国拜耳(Bayer)医疗药物公司的首席工程师,也是拜耳销售最好大分子药物(Kogenate FS)的工业生产专家。在他职业生涯的早期阶段,他担任美国安进(Amgen)公司的资深科学家,致力于临床药品制剂和设备的优化,为安进公司销售上市药物(Prolia)三期临床生产以及商业开展做出贡献。在加入安进公司之前,他在MedImmune公司担任资深科学家,从事疫苗的工艺开发及优化。 此前他曾在Vertex制药公司,及比利时制药公司UCB Pharma各工作多年,致力于通过靶向药物提纯、高通量药物筛选和生物化学/生物物理特性来进行药物结构的设计。
着前FDA的生物制品CMC资深审评主任刘巨洪博士
刘巨洪博士
着前FDA的生物制品CMC资深审评主任
对生物药的开发和上市申报策略有着丰富的经验。刘巨洪博士毕业于协和医科大学基础医学部,与1995年起在美国国立癌症研究所从事了十年以上的蛋白质表达及功能性研究。2008进入美国FDA蛋白生物产品审评部。历任生物制品CMC审评员,审评组长,审评主任。参与或主管全球25%生物制品BLA和IND审评工作。刘巨洪博士于2018年离开FDA,致力于协助新兴生物制品公司开发生物制品并获得全球化商业生产的审批。
Director, Boehringer IngelheimMrs Min Zhu
Mrs Min Zhu
Director, Boehringer Ingelheim
Professor,Kobe UniversityLee Ineui
Lee Ineui
Professor,Kobe University
She received her PhD in Agricultural Chemistry, University of Tokyo in Japan. She had joined to the filtration company ‘Nihon Pall Ltd., Scientific & Laboratory。Services Div.’, for 15 years, and worked for the sterile filtration process validation including extractables/leachables, endotoxin or virus removal for the bio-pharmaceutical industries in Japan. And she served as ISO TC 198 WG9 member, and research member of Human Science Agency, for the studies on process validation and scientific qualification in the drug manufacturing in Japan. After that, she had joined to ‘Chugai Pharmaceutical Co. Ltd.’, CMC Regulatory Affairs Division, for 12 years. As a CMC regulatory affairs personnel, she mainly worked for CMC submission to the global and Japan health authorities for the drug approval of monoclonal antibody developed by biotechnology. Currently, she is a specially appointed professor in Kobe University, Graduate School of Science, Technology Innovation, and is also a director of Biologics Center for Research and Training at Kobe University newly installed in 2017. She joined Technology Working Committee of Biopharmaceutical Committee in JPMA in 2012-2016, and worked as a member of Scientific Organization committee on CASSS CMC Strategy Forum Japan from 2012-2016. She is currently participating in Japan PDA viral safety committee, CASSS associate director’s meeting, and director of the Biologics Center for Research & Technology (BCRET).
Transcenta 创胜集团 CTOChris Hwang 黄光诚博士
Chris Hwang 黄光诚博士
Transcenta 创胜集团 CTO
Chris Hwang, Ph.D. is Chief Technology Officer at Transcenta Holding. Transcenta is a global biotherapeutic company that fully integrates discovery technology, translational medicine research, clinical and commercial development and manufacturing capabilities for therapeutic biologics, focusing on developing innovative and transformative medicine at an affordable price to patients around the world. As CTO, he is responsible for developing and implementing innovative technologies to achieve best–in-class process and product development while dramatically expand global access to biotherapeutics. Prior to joining Transcenta in 2016, he spent 25 years at Genzyme and Sanofi, most recently as Senior Director in Late Stage Process Development and program lead for the industry-leading continuous bioprocessing platform. He has extensive experience in product and CMC development, technology transfer, GMP manufacturing and manufacturing support. Previously he managed departments responsible for cell culture and microbial fermentation development, process analytics, gene therapy development, clinical manufacturing, project portfolio management and was the Operations Technical Lead for a number of mid to late-stage clinical and commercial biologics at Genzyme. Chris received his B.S. in chemical engineering and Ph.D. in biochemical engineering from Massachusetts Institute of Technology.
北大未名生物 CEO李树德
李树德
北大未名生物 CEO
李树德,现任北大未名生物制药首席执行官。曾任 博威生物医药有限公司高级副总裁;百济神州项目工程总监,武汉喜康生物医药公司厂长,德国罗曼集团台湾区副总经理,成都迪瑞药业公司公司副总经理。负责上述生物制药公司新厂的筹建。上海百迈博制药公司副总经理,领导在上海建立全新的单克隆抗体药物GMP生产工厂。梅里亚公司(Merial)中国区的生产项目总监。梅里亚曾是美国默克制药公司和法国赛诺菲集团的合资公司,公司中国区的三个工厂的业务是疫苗与药品的生产与营销。神隆公司 (ScinoPharm) 技术处长,负责生产技术、质量保证、实验室、物料/采购、ERP 企业资源规划管理系统; 参与建成了价值2亿美元的新厂,并获得了美国FDA的cGMP 认证,建立了全新的ERP企业资源规划管理系统(SAP)。葛兰素史克公司(GSK)台湾厂的厂长,负责推动了新产品的开发与上市,并领导了生产厂的扩建项目,以提高产能。工厂获得了由TGA澳大利亚国家药物总局的GMP 认证。罗氏公司(Roche)台湾厂的厂长/上海罗氏的技术副总经理,领导在台湾和上海建立全新的GMP生产厂。并兼任韩国罗氏的技术顾问,协助强化其质量管理体系。德国勃林格殷格翰公司 (Boehringer Ingelheim) 台湾厂的厂长,领导建立全新的GMP 生产厂,并领导了工厂的扩建项目。
Chief Scientific Officer, LonzaUwe Gottschalk
Uwe Gottschalk
Chief Scientific Officer, Lonza
副总裁,浙江特瑞思医药冉兆祥 博士
冉兆祥 博士
副总裁,浙江特瑞思医药
Process development (upstream cell culture), tech transfer and scale up. More than 25 years of experience in academic and biopharmaceutical industry including Merck, NIH, and J&J. Participated or led Remicade, Stelera & Golimumab product development and commercial launch/ support. Led 20000L scale up and tech transfer of Phase III mAb (CNTO 888)fed batch process to CMO. Award winner for process excellence (24 g/L Fed-Perfusion in 12 days)。
Associate Manager,Shin Nippon Biomedical Laboratories, JapanSakae Kohara
Sakae Kohara
Associate Manager,Shin Nippon Biomedical Laboratories, Japan
Sakae Kohara was involved in genome sequencing of the rat and rhesus m MHC regions as a research fellow at Tokai University School of Medicine after he earned M.S degree from Tokyo University of Agriculture. Thereafter, he has engaged in molecular biology research, mainly gene and genome analysis of cynomolgus monkeys, since he joined Shin Nippon Biomedical Laboratories.
Vice President, LSPD-TT- TopAlliance 君实生物Donald Palahnuk
Donald Palahnuk
Vice President, LSPD-TT- TopAlliance 君实生物
GM, BioProcess Automation and Digital, GE HealthcareMr. Kevin Seaver
Mr. Kevin Seaver
GM, BioProcess Automation and Digital, GE Healthcare
Executive Director, Marketing, PallDr Peter Levison
Dr Peter Levison
Executive Director, Marketing, Pall
In his current position within Pall Biotech, Peter Levison is responsible for developing strategic partnerships within the Biotech community through the management of a network of Global Thought Leaders. Working with key industrialists and academics around the world, Peter is actively looking for solutions to tomorrow’s challenges today. Peter has over 25 years experience in the biopharmaceutical industry, holding positions of increasing responsibility in research and development, technical management, and product management. Peter holds a BSc (Hons) and a PhD gained in the Dept. of Biochemistry, University of Manchester, UK and an MBA awarded through the Open University Business School, UK.
Head of mAb and Recombinant Protein Market Segment-Sartorius Stedim Biotech GmbHMiriam Monge
Miriam Monge
Head of mAb and Recombinant Protein Market Segment-Sartorius Stedim Biotech GmbH
Miriam has 25 years of experience in the biopharmaceutical industry and is best known for her contribution during the pioneering phase of single-use technologies as Marketing Director for Stedim Biosystems. Miriam founded and chaired the ISPE global disposables community of practice in 2008 aimed both at promoting education and evaluating the global regulatory requirements for single-use technologies. Miriam has published widely & notably co-authored a regular column‘the disposables advisor’ for several years in Biopharm International, is a senior visiting lecturer at UCL London dept. of biochemical engineering and an editorial advisor for Bioprocess International. Miriam spent 6 years as a Principal consultant at a bioprocess consultancy Biopharm Services where she built the BioSolve bioprocess modelling business supporting clients in designing robust processes whilst optimizing costs throughout the molecule lifecycle. During this time Miriam was an SME and internal consultant on single-use strategy & implementation for major biopharma’s such as Sanofi, and CDMO’s BI and CMC biologics (now AGC biologics). Since 2014 at Sartorius Stedim Miriam built a global process development team, successfully implemented bioprocess platform programs for mAbs, viral vectors, ADC’s, intensified | continuous processing with related services from PD to CGMP commercial scale. In in her new role she is Head of the mAb and Recombinant Protein Market Segment at Sartorius. Miriam successfully completed the MBI programme at UCL, London and an MBA from Marseille ‘Ecole Superieure de Commerce’ International Business School.
Global Tech Expert, Sartorius Stedim Biotech GmbHGerben Zijlstra
Gerben Zijlstra
Global Tech Expert, Sartorius Stedim Biotech GmbH
Gerben is a regular speaker on process intensification, process integration and continuous biomanufacturing. He received his Ph.D. from the University of Wageningen (The Netherlands) in the field of process integration in animal cell culture. He has worked for more than 20 years at CMO DSM Biologics and has been involved in the development of several commercial Bio-therapeutics, as well as innovation projects. He was one of the early adopters of single-use bioreactors and is the first inventor of the Concentrated Fed-Batch-XD® technology, amongst others licensed by Amgen. Gerben was deeply involved in the scale-up and tech transfer of XD® technology to the Brisbane (Australia) site, which later received the 2014 ISPE facility of the year award for process innovations. Subsequently, as a Consultant at Xendo, Gerben has been working on several Continuous BioManufacturing as well as Gene Therapy projects. Since end of 2016 he has joined the Sartorius Stedim Biotech Marketing Team, where he currently holds a position as Global Tech Expert for Intensified and Continuous BioManufacturing.
Scientist at Asahi Kasei Bioprocess AmericaMrs. Julie J. Mouannes
Mrs. Julie J. Mouannes
Scientist at Asahi Kasei Bioprocess America
Leading projects to optimize downstream bioprocess unit operations with a focus on virus filtration and communicating results internally and externally. Collaborating with customers in the bio pharmaceutical industry to provide technical knowledge, address concerns and build collaborative relationships.
Vice President, RepligenSteve Tingley
Steve Tingley
Vice President, Repligen
浙江大学化学工程与生物工程学院教授,博士生导师林东强教授
林东强教授
浙江大学化学工程与生物工程学院教授,博士生导师
Dong-Qiang Lin, professor at College of Chemical and Biological Engineering, Zhejiang University. He graduated from Zhejiang University in 1992, and then obtained Ph.D. in 1997. Since 1998, he work for Zhejiang University, and became a professor in 2007. He also worked as post-doctor in Germany and visited Germany and USA several times as the visiting professor. Till now he has published more than 140 peer-reviewed papers in international journals and three books, and was authorized 36 patents. He got several technical awards, such as the First Award of Technology Progress (Education Ministry of China), Second Award of Technology Progress (Zhejiang Province), Second Award of Natural Science (Zhejiang Province). He focused on downstream processing, including new resins, separation technology, process design, and continuous manufacturing. (http://person.zju.edu.cn/0098032)
生物工艺研究所,高级科学家,A*STAR宋志伟 博士
宋志伟 博士
生物工艺研究所,高级科学家,A*STAR
Dr. Song Zhiwei obtained his Ph.D. degree in Biochemistry from the University of Michigan where he studied plant lectins and protein glycosylation in cancer cells. His post-doc work was completed in the Biology Department at Massachusetts Institute of Technology (MIT) where he studied genetic control of apoptosis. After that, he worked in Professor Daniel I.C. Wang’s lab in the Biotechnology Process Engineering Center (BPEC) at MIT. In 2002, Dr. Song moved to Singapore. Currently, he is a Senior Principal Scientist at the Bioprocessing Technology Institute (BTI) of A*STAR. His lab has been focused on protein glycosylation, glycoengineering of CHO cells with different genome editing techniques and production of antibodies with these glycosylation mutants for in vitro and in vivo characterizations. Over the years, his lab has collaborated with several major international biotech companies on various projects.
Principal Scientist, AmgenDr Yusdy Pan
Dr Yusdy Pan
Principal Scientist, Amgen
浙江华海生物, 总经理苏建华 博士 (TBD)
苏建华 博士 (TBD)
浙江华海生物, 总经理
苏建华博士是一位在大型跨国药企拥有多年丰富经验的战略领导者。他精通上游和下游工艺开发、工艺改进、技术转移、验证、生产以及合规运营等方面。在美国工作期间,苏博士曾经在辉瑞、赛诺菲和默沙东担任重要的领导岗位。他具有在美国15年以上的团队及项目管理经验。苏博士毕业于天津大学化学工程系,之后在美国西弗吉尼亚大学化学工程专业获得博士学位。苏博士于2014年9月回国, 在药明生物担任技术转移执行总监。他于2015年6月加入恒瑞医药,任苏州盛迪亚生物医药有限公司总经理。自2017年初,苏博士加盟华海药业任华海生物总经理。
副总裁,信达生物徐炜博士 (TBD)
徐炜博士 (TBD)
副总裁,信达生物
负责生产,包括技术转移、原液、制剂、配液支持等。美国印第安纳大学工商管理硕士。曾先后担任舒迪安、阿斯利康、百时美施贵宝、安进等公司的管理和技术职位。在工艺开发、产业化转化、大型生物制药新厂投产项目等领域有20多年的经验。
Vice President and General Manager, USP-ChinaGeoff Tsen 岑国山  (TBD)
Geoff Tsen 岑国山 (TBD)
Vice President and General Manager, USP-China
副总裁,Transcenta Holding杨晓明博士
杨晓明博士
副总裁,Transcenta Holding
国家“千人计划”特聘专家 工艺与产品开发高级副总裁 在生物医药行业拥有超过 25 年经验,入选中国“国家千人计 划” 曾任职于默克、艾尔建和安进 罗格斯大学博士
Research,Daiichi SankyoTakuya Miyano
Takuya Miyano
Research,Daiichi Sankyo
Global DSP Tech ConsultantGanesh Kumar
Ganesh Kumar
Global DSP Tech Consultant
Ganesh Kumar has over six years of experience in the bio-pharmaceutical industry both as an end-user and as a solution provider. He holds a Master’s degree in Chemical and Bioprocess Engineering from Hamburg University of Technology (TU Hamburg), Germany. He started off his career in 2013 as a DSP Process Development Engineer within the Manufacturing Sciences and Technology (MSAT) group at Lonza, Singapore. Over a period of three years, he was actively involved in the tech-transfer, validation and large-scale commercial manufacturing of three key block-buster mAbs. He also led and participated various operational excellence programs such as improving DSP yield, error prevention scheme, reduction in changeover times and as a result was a recipient of multiple excellence awards at Lonza. Ganesh joined Sartorius in 2016 as a Process Engineer | Consultant within the Integrated Solutions team based in Guxhagen, Germany. In this role, he managed as well as executed several single-use | stainless steel DSP projects and was one of the key contributors in shaping the P4S® conceptual design platform that enables customers to choose a process centric approach towards SU facility design. Since April 2019, Ganesh holds a position as a Global DSP Tech Consultant in the area of Intensified and Continuous Biomanufacturing within Sartorius.
Scott Liu 刘世高博士 (TBD)
2020第二届亚洲生物制药连续生产及工艺创新峰会
首席执行官 复宏汉霖
刘世高博士, 复星国际全球合伙人,复宏汉霖联合创始人、总裁兼首席执行官。在他的带领之下,复宏汉霖致力于应用前沿技术进行单克隆抗体生物类似药、生物改良药以及创新单抗的研发及产业化,专注于提供质高价优的生物药,已成为中国单抗领域的领跑者。在2010年组建复宏汉霖之前,刘博士曾先后担任美国UBI公司副总裁、美国百时美施贵宝(Bristol-Myers Squibb)公司及安进(Amgen)公司的质量控制总监,拥有超过25年的生技药品研发、生产制造、药政及质量管理经验。由于其杰出成就,刘博士曾获得施贵宝公司的技术运营成就奖和瞩目焦点奖。刘博士为推动国内蛋白药物质量标准建立与提升做出了具体贡献; 在国内率先引进先进的一次性生产技术用于单抗药物研发以及产业化生产; 并积极参与《生物类似药研发与评价技术指导原则》的意见征询,推动国内生物医药行业健康发展。刘博士于1991年获得美国普渡大学生物系博士学位,而后于斯坦福大学进行博士后研究,并攻读雪城大学iMBA课程。
Peter Shen 沈克强
2020第二届亚洲生物制药连续生产及工艺创新峰会
副总裁,药明生物
25年以上纯化工艺开发和GMP生产经验,曾任美国Laurate Biopharm纯化及GMP生产总监,美国强生公司高级研究员、经理,曾就职于百时美施贵宝和杜邦制药,新墨西哥州立大学硕士。
刘洵博士
2020第二届亚洲生物制药连续生产及工艺创新峰会
恒瑞医药副总经理
刘洵博士,北京大学化学系本科毕业,1993年获得美国罗格斯大学生物化学博士学位,同年获得博士后奖学金,在诺贝尔奖获得者Gobind Khorana教授所在的麻省理工大学从事蛋白生物研究,在此完成三年半的博士后研究。在国外有影响力的期刊发表诸多学术论文。 刘洵博士拥有20多年的生物制药研发,临床和工业生产经验,在制药领域涉及很多新药研发以及工艺优化的研究,包括从临床前的研究开发直至商业生产。 加入恒瑞医药前,他是美国国立卫生研究院疫苗研究中心疫苗生产项目的工艺开发总监。负责大分子药物开发和临床药物生产,期间完成多个生物药物的临床申报。在加入美国国立卫生研究院(NIH)疫苗研究中心之前,刘洵博士担任位于美国拜耳(Bayer)医疗药物公司的首席工程师,也是拜耳销售最好大分子药物(Kogenate FS)的工业生产专家。在他职业生涯的早期阶段,他担任美国安进(Amgen)公司的资深科学家,致力于临床药品制剂和设备的优化,为安进公司销售上市药物(Prolia)三期临床生产以及商业开展做出贡献。在加入安进公司之前,他在MedImmune公司担任资深科学家,从事疫苗的工艺开发及优化。 此前他曾在Vertex制药公司,及比利时制药公司UCB Pharma各工作多年,致力于通过靶向药物提纯、高通量药物筛选和生物化学/生物物理特性来进行药物结构的设计。
刘巨洪博士
2020第二届亚洲生物制药连续生产及工艺创新峰会
着前FDA的生物制品CMC资深审评主任
对生物药的开发和上市申报策略有着丰富的经验。刘巨洪博士毕业于协和医科大学基础医学部,与1995年起在美国国立癌症研究所从事了十年以上的蛋白质表达及功能性研究。2008进入美国FDA蛋白生物产品审评部。历任生物制品CMC审评员,审评组长,审评主任。参与或主管全球25%生物制品BLA和IND审评工作。刘巨洪博士于2018年离开FDA,致力于协助新兴生物制品公司开发生物制品并获得全球化商业生产的审批。
Lee Ineui
2020第二届亚洲生物制药连续生产及工艺创新峰会
Professor,Kobe University
She received her PhD in Agricultural Chemistry, University of Tokyo in Japan. She had joined to the filtration company ‘Nihon Pall Ltd., Scientific & Laboratory。Services Div.’, for 15 years, and worked for the sterile filtration process validation including extractables/leachables, endotoxin or virus removal for the bio-pharmaceutical industries in Japan. And she served as ISO TC 198 WG9 member, and research member of Human Science Agency, for the studies on process validation and scientific qualification in the drug manufacturing in Japan. After that, she had joined to ‘Chugai Pharmaceutical Co. Ltd.’, CMC Regulatory Affairs Division, for 12 years. As a CMC regulatory affairs personnel, she mainly worked for CMC submission to the global and Japan health authorities for the drug approval of monoclonal antibody developed by biotechnology. Currently, she is a specially appointed professor in Kobe University, Graduate School of Science, Technology Innovation, and is also a director of Biologics Center for Research and Training at Kobe University newly installed in 2017. She joined Technology Working Committee of Biopharmaceutical Committee in JPMA in 2012-2016, and worked as a member of Scientific Organization committee on CASSS CMC Strategy Forum Japan from 2012-2016. She is currently participating in Japan PDA viral safety committee, CASSS associate director’s meeting, and director of the Biologics Center for Research & Technology (BCRET).
Chris Hwang 黄光诚博士
2020第二届亚洲生物制药连续生产及工艺创新峰会
Transcenta 创胜集团 CTO
Chris Hwang, Ph.D. is Chief Technology Officer at Transcenta Holding. Transcenta is a global biotherapeutic company that fully integrates discovery technology, translational medicine research, clinical and commercial development and manufacturing capabilities for therapeutic biologics, focusing on developing innovative and transformative medicine at an affordable price to patients around the world. As CTO, he is responsible for developing and implementing innovative technologies to achieve best–in-class process and product development while dramatically expand global access to biotherapeutics. Prior to joining Transcenta in 2016, he spent 25 years at Genzyme and Sanofi, most recently as Senior Director in Late Stage Process Development and program lead for the industry-leading continuous bioprocessing platform. He has extensive experience in product and CMC development, technology transfer, GMP manufacturing and manufacturing support. Previously he managed departments responsible for cell culture and microbial fermentation development, process analytics, gene therapy development, clinical manufacturing, project portfolio management and was the Operations Technical Lead for a number of mid to late-stage clinical and commercial biologics at Genzyme. Chris received his B.S. in chemical engineering and Ph.D. in biochemical engineering from Massachusetts Institute of Technology.
李树德
2020第二届亚洲生物制药连续生产及工艺创新峰会
北大未名生物 CEO
李树德,现任北大未名生物制药首席执行官。曾任 博威生物医药有限公司高级副总裁;百济神州项目工程总监,武汉喜康生物医药公司厂长,德国罗曼集团台湾区副总经理,成都迪瑞药业公司公司副总经理。负责上述生物制药公司新厂的筹建。上海百迈博制药公司副总经理,领导在上海建立全新的单克隆抗体药物GMP生产工厂。梅里亚公司(Merial)中国区的生产项目总监。梅里亚曾是美国默克制药公司和法国赛诺菲集团的合资公司,公司中国区的三个工厂的业务是疫苗与药品的生产与营销。神隆公司 (ScinoPharm) 技术处长,负责生产技术、质量保证、实验室、物料/采购、ERP 企业资源规划管理系统; 参与建成了价值2亿美元的新厂,并获得了美国FDA的cGMP 认证,建立了全新的ERP企业资源规划管理系统(SAP)。葛兰素史克公司(GSK)台湾厂的厂长,负责推动了新产品的开发与上市,并领导了生产厂的扩建项目,以提高产能。工厂获得了由TGA澳大利亚国家药物总局的GMP 认证。罗氏公司(Roche)台湾厂的厂长/上海罗氏的技术副总经理,领导在台湾和上海建立全新的GMP生产厂。并兼任韩国罗氏的技术顾问,协助强化其质量管理体系。德国勃林格殷格翰公司 (Boehringer Ingelheim) 台湾厂的厂长,领导建立全新的GMP 生产厂,并领导了工厂的扩建项目。
冉兆祥 博士
2020第二届亚洲生物制药连续生产及工艺创新峰会
副总裁,浙江特瑞思医药
Process development (upstream cell culture), tech transfer and scale up. More than 25 years of experience in academic and biopharmaceutical industry including Merck, NIH, and J&J. Participated or led Remicade, Stelera & Golimumab product development and commercial launch/ support. Led 20000L scale up and tech transfer of Phase III mAb (CNTO 888)fed batch process to CMO. Award winner for process excellence (24 g/L Fed-Perfusion in 12 days)。
Sakae Kohara
2020第二届亚洲生物制药连续生产及工艺创新峰会
Associate Manager,Shin Nippon Biomedical Laboratories, Japan
Sakae Kohara was involved in genome sequencing of the rat and rhesus m MHC regions as a research fellow at Tokai University School of Medicine after he earned M.S degree from Tokyo University of Agriculture. Thereafter, he has engaged in molecular biology research, mainly gene and genome analysis of cynomolgus monkeys, since he joined Shin Nippon Biomedical Laboratories.
Dr Peter Levison
2020第二届亚洲生物制药连续生产及工艺创新峰会
Executive Director, Marketing, Pall
In his current position within Pall Biotech, Peter Levison is responsible for developing strategic partnerships within the Biotech community through the management of a network of Global Thought Leaders. Working with key industrialists and academics around the world, Peter is actively looking for solutions to tomorrow’s challenges today. Peter has over 25 years experience in the biopharmaceutical industry, holding positions of increasing responsibility in research and development, technical management, and product management. Peter holds a BSc (Hons) and a PhD gained in the Dept. of Biochemistry, University of Manchester, UK and an MBA awarded through the Open University Business School, UK.
Miriam Monge
2020第二届亚洲生物制药连续生产及工艺创新峰会
Head of mAb and Recombinant Protein Market Segment-Sartorius Stedim Biotech GmbH
Miriam has 25 years of experience in the biopharmaceutical industry and is best known for her contribution during the pioneering phase of single-use technologies as Marketing Director for Stedim Biosystems. Miriam founded and chaired the ISPE global disposables community of practice in 2008 aimed both at promoting education and evaluating the global regulatory requirements for single-use technologies. Miriam has published widely & notably co-authored a regular column‘the disposables advisor’ for several years in Biopharm International, is a senior visiting lecturer at UCL London dept. of biochemical engineering and an editorial advisor for Bioprocess International. Miriam spent 6 years as a Principal consultant at a bioprocess consultancy Biopharm Services where she built the BioSolve bioprocess modelling business supporting clients in designing robust processes whilst optimizing costs throughout the molecule lifecycle. During this time Miriam was an SME and internal consultant on single-use strategy & implementation for major biopharma’s such as Sanofi, and CDMO’s BI and CMC biologics (now AGC biologics). Since 2014 at Sartorius Stedim Miriam built a global process development team, successfully implemented bioprocess platform programs for mAbs, viral vectors, ADC’s, intensified | continuous processing with related services from PD to CGMP commercial scale. In in her new role she is Head of the mAb and Recombinant Protein Market Segment at Sartorius. Miriam successfully completed the MBI programme at UCL, London and an MBA from Marseille ‘Ecole Superieure de Commerce’ International Business School.
Gerben Zijlstra
2020第二届亚洲生物制药连续生产及工艺创新峰会
Global Tech Expert, Sartorius Stedim Biotech GmbH
Gerben is a regular speaker on process intensification, process integration and continuous biomanufacturing. He received his Ph.D. from the University of Wageningen (The Netherlands) in the field of process integration in animal cell culture. He has worked for more than 20 years at CMO DSM Biologics and has been involved in the development of several commercial Bio-therapeutics, as well as innovation projects. He was one of the early adopters of single-use bioreactors and is the first inventor of the Concentrated Fed-Batch-XD® technology, amongst others licensed by Amgen. Gerben was deeply involved in the scale-up and tech transfer of XD® technology to the Brisbane (Australia) site, which later received the 2014 ISPE facility of the year award for process innovations. Subsequently, as a Consultant at Xendo, Gerben has been working on several Continuous BioManufacturing as well as Gene Therapy projects. Since end of 2016 he has joined the Sartorius Stedim Biotech Marketing Team, where he currently holds a position as Global Tech Expert for Intensified and Continuous BioManufacturing.
Mrs. Julie J. Mouannes
2020第二届亚洲生物制药连续生产及工艺创新峰会
Scientist at Asahi Kasei Bioprocess America
Leading projects to optimize downstream bioprocess unit operations with a focus on virus filtration and communicating results internally and externally. Collaborating with customers in the bio pharmaceutical industry to provide technical knowledge, address concerns and build collaborative relationships.
林东强教授
2020第二届亚洲生物制药连续生产及工艺创新峰会
浙江大学化学工程与生物工程学院教授,博士生导师
Dong-Qiang Lin, professor at College of Chemical and Biological Engineering, Zhejiang University. He graduated from Zhejiang University in 1992, and then obtained Ph.D. in 1997. Since 1998, he work for Zhejiang University, and became a professor in 2007. He also worked as post-doctor in Germany and visited Germany and USA several times as the visiting professor. Till now he has published more than 140 peer-reviewed papers in international journals and three books, and was authorized 36 patents. He got several technical awards, such as the First Award of Technology Progress (Education Ministry of China), Second Award of Technology Progress (Zhejiang Province), Second Award of Natural Science (Zhejiang Province). He focused on downstream processing, including new resins, separation technology, process design, and continuous manufacturing. (http://person.zju.edu.cn/0098032)
宋志伟 博士
2020第二届亚洲生物制药连续生产及工艺创新峰会
生物工艺研究所,高级科学家,A*STAR
Dr. Song Zhiwei obtained his Ph.D. degree in Biochemistry from the University of Michigan where he studied plant lectins and protein glycosylation in cancer cells. His post-doc work was completed in the Biology Department at Massachusetts Institute of Technology (MIT) where he studied genetic control of apoptosis. After that, he worked in Professor Daniel I.C. Wang’s lab in the Biotechnology Process Engineering Center (BPEC) at MIT. In 2002, Dr. Song moved to Singapore. Currently, he is a Senior Principal Scientist at the Bioprocessing Technology Institute (BTI) of A*STAR. His lab has been focused on protein glycosylation, glycoengineering of CHO cells with different genome editing techniques and production of antibodies with these glycosylation mutants for in vitro and in vivo characterizations. Over the years, his lab has collaborated with several major international biotech companies on various projects.
苏建华 博士 (TBD)
2020第二届亚洲生物制药连续生产及工艺创新峰会
浙江华海生物, 总经理
苏建华博士是一位在大型跨国药企拥有多年丰富经验的战略领导者。他精通上游和下游工艺开发、工艺改进、技术转移、验证、生产以及合规运营等方面。在美国工作期间,苏博士曾经在辉瑞、赛诺菲和默沙东担任重要的领导岗位。他具有在美国15年以上的团队及项目管理经验。苏博士毕业于天津大学化学工程系,之后在美国西弗吉尼亚大学化学工程专业获得博士学位。苏博士于2014年9月回国, 在药明生物担任技术转移执行总监。他于2015年6月加入恒瑞医药,任苏州盛迪亚生物医药有限公司总经理。自2017年初,苏博士加盟华海药业任华海生物总经理。
徐炜博士 (TBD)
2020第二届亚洲生物制药连续生产及工艺创新峰会
副总裁,信达生物
负责生产,包括技术转移、原液、制剂、配液支持等。美国印第安纳大学工商管理硕士。曾先后担任舒迪安、阿斯利康、百时美施贵宝、安进等公司的管理和技术职位。在工艺开发、产业化转化、大型生物制药新厂投产项目等领域有20多年的经验。
杨晓明博士
2020第二届亚洲生物制药连续生产及工艺创新峰会
副总裁,Transcenta Holding
国家“千人计划”特聘专家 工艺与产品开发高级副总裁 在生物医药行业拥有超过 25 年经验,入选中国“国家千人计 划” 曾任职于默克、艾尔建和安进 罗格斯大学博士
Ganesh Kumar
2020第二届亚洲生物制药连续生产及工艺创新峰会
Global DSP Tech Consultant
Ganesh Kumar has over six years of experience in the bio-pharmaceutical industry both as an end-user and as a solution provider. He holds a Master’s degree in Chemical and Bioprocess Engineering from Hamburg University of Technology (TU Hamburg), Germany. He started off his career in 2013 as a DSP Process Development Engineer within the Manufacturing Sciences and Technology (MSAT) group at Lonza, Singapore. Over a period of three years, he was actively involved in the tech-transfer, validation and large-scale commercial manufacturing of three key block-buster mAbs. He also led and participated various operational excellence programs such as improving DSP yield, error prevention scheme, reduction in changeover times and as a result was a recipient of multiple excellence awards at Lonza. Ganesh joined Sartorius in 2016 as a Process Engineer | Consultant within the Integrated Solutions team based in Guxhagen, Germany. In this role, he managed as well as executed several single-use | stainless steel DSP projects and was one of the key contributors in shaping the P4S® conceptual design platform that enables customers to choose a process centric approach towards SU facility design. Since April 2019, Ganesh holds a position as a Global DSP Tech Consultant in the area of Intensified and Continuous Biomanufacturing within Sartorius.
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